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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Speech Generating Device - Dell Venue Windows - 10"
Lingraphicare America, Inc.
TouchTalk
In Commercial Distribution

  • 00850042278109 ()


  • Voice synthesizer/digitizer
Dynamyx Digital Pathology Software is intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software. The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica’s Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips’ Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips’ Ultra Fast Scanner and Philips PP27QHD monitor.
OMNYX, LLC
2.4
In Commercial Distribution

  • 00860007120206 ()


  • Pathology information system application software
No Description
BUY SUPPLY INC
PG-IRT1602
In Commercial Distribution

  • 00860004330691 ()


  • Infrared patient thermometer, ear
Competitor Inventory Buy Back Product
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690BUYBACK2 ()
BUYBACK

  • Carbide dental bur, single-use
KIT, TOTAL KNEE
Cardinal Health 200, LLC
PO23TKBUY
In Commercial Distribution

  • 50888439901649 ()
  • 10888439901641 ()
PO23TKBUY

  • Orthopaedic surgical procedure kit, medicated
Laptop Instructor DELL 7710 (Trade Show)
ZIRKONZAHN SRL
WRAB5161
In Commercial Distribution

  • D800WRAB5161 ()


  • Dental milling system, CAD/CAM, laboratory
Dell LRI astigmatism marker (Nichamin Nomogram), 4 3/4'', 40/60/80 degree markings, rotating ring with degree markings, round handle, titanium
AMBLER SURGICAL CORP.
Dell LRI astigmatism marker (Nichamin Nomogram)
In Commercial Distribution

  • 00190660104245 ()
8302T

  • Scleral marker, reusable
Dell LRI astigmatism marker (Gills Nomogram), 4 3/4'', marks chord length of 6.0mm and 8.0mm, rotating ring with degree markings, round handle, titanium
AMBLER SURGICAL CORP.
Dell LRI astigmatism marker (Gills Nomogram)
In Commercial Distribution

  • 00190660104238 ()
8301T

  • Scleral marker, reusable
ASSY-LAU, PANDA IN-BED SCALE, Finished good - Buy
Datex-Ohmeda, Inc.
PS1
In Commercial Distribution

  • 00840682143721 ()


  • Infant scale, electronic
ASSY-LAU, GIRAFFE IN-BED SCALE EU, Finished good - Buy
DATEX-OHMEDA INC
GS EU1
Not in Commercial Distribution

  • 00840682143714 ()


  • Infant scale, electronic
ASSY-LAU, GIRAFFE IN-BED SCALE, Finished good - Buy
Datex-Ohmeda, Inc.
GS1
In Commercial Distribution

  • 00840682143677 ()


  • Infant scale, electronic
ASSY-LAU, PANDA IN-BED SCALE EU, Finished good - Buy
DATEX-OHMEDA INC
PS EU1
Not in Commercial Distribution

  • 00840682143660 ()


  • Infant scale, electronic
planning station DELL 3560 Querty power plug B for Rosa One 3.1.6
MEDTECH
164050
In Commercial Distribution

  • 03760244034922 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system
planning station DELL 7520 Querty power plug B for Rosa One 3.1.4.0
MEDTECH
164017
In Commercial Distribution

  • 03760244033840 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system
planning station DELL 7520 Querty power plug B for Rosa One 3.1.1.0
MEDTECH
164017-00
Not in Commercial Distribution

  • 03760244032652 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system
planning station DELL 3560 QUERTY power plug B for Rosa One 3.1.5
MEDTECH
164050
In Commercial Distribution

  • 03760244035127 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system
planning station DELL 7520 Querty power plug B for Rosa One 3.1.5 (Brain application)
MEDTECH
164017
In Commercial Distribution

  • 03760244034403 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system
ROSA PLANNING STATION Laptop computer with the following minimal configuration : Windows 7, intel Pentium processor, 15,6'' screen, DVD +/- RW, USB ports, 25GB graphics card, eternet connection for PACS interface with graphical user interface for surgical planning, pre-operative navigation and frameless streotaxy.
MEDTECH
DELL 7520
Not in Commercial Distribution

  • 03760244030375 ()
ROSAS00369

  • Multi-purpose stereotactic surgery system
  • Neurological stereotactic surgery system
LRI Marker, 6mm & 8mm Chord Lengths, With Degree Gauge (Uses Dell/Gills Nomograms)
AURORA SURGICAL, LLC
AS3-500
In Commercial Distribution

  • 08175700109505 ()
AS3-500

  • Ophthalmic angular gauge, reusable
DELL ASTIGMATISM MARKER GILLS and
Avalign Technologies, Inc.
92-CM01302
In Commercial Distribution

  • 00190776200282 ()


  • Corneal marker, reusable
IHS Inclinometer (Della Valle Inclinometer)
INNOMED, INC.
1326
In Commercial Distribution

  • 00840277122803 ()
1326

  • Surgical drill guide, reusable
A SINGLE, STERILE CUP THAT ATTACHES TO A PLATFORM (NOT INCLUDED) TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE. THIS CUP IS SOLD SINGLY TO ACCOMMODATE HOSPITALS WHO WISH TO BUY IN BULK. HOWEVER TWO CUPS ARE REQUIRED TO BE ATTACHED TO THE PLATFORM WHEN IT IS BEING USED.
JB Medical Development, LLC
14-101-01
In Commercial Distribution

  • B99214101010 ()
1410101

  • Surgical instrument interim-placement holder, single-use
Colour touch screen Dell 24 Touch monitor- P2418HT - 60.5 cm (23.8) Black ITL for Zirkonzahn scanner
ZIRKONZAHN SRL
KT004118
In Commercial Distribution

  • D800KT004118 ()


  • Dental milling system, CAD/CAM, laboratory
AMSTRON AP-1222OEV BATTERY MUST BUY TWO
AADCO MEDICAL, INC.
OSP-AP12220EV
In Commercial Distribution

  • 00840348505283 ()
OSP-AP12220EV

  • Custom-made medical device mount
Dell 6 BUTTON LASER MOUSE
Leica Biosystems Richmond, Inc.
23MOS0002
Not in Commercial Distribution

  • 00849832013426 ()

  • Device Size Text, specify:


  • Desktop computer
Dell Precision 5820
Leica Biosystems Richmond, Inc.
23CPU1066
Not in Commercial Distribution

  • 00849832013372 ()

  • Device Size Text, specify:


  • Desktop computer
Dell Laser Mouse
Leica Biosystems Richmond, Inc.
23MOS0001
Not in Commercial Distribution

  • 00849832013181 ()

  • Device Size Text, specify:


  • Desktop computer
Leica Biosystems CytoVision Dell Ultrasharp U2415 Monitor
Leica Biosystems Richmond, Inc.
23MON0024
Not in Commercial Distribution

  • 00849832010623 ()

  • Device Size Text, specify:


  • Image display unit, colour
Leica Biosystems CytoVision HD Image, Dell 5810 RAID1 Win 7 Pro
Leica Biosystems Richmond, Inc.
23DKI5817
Not in Commercial Distribution

  • 00849832009887 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive
Leica Biosystems CytoVision HD Image, Dell 5810 Basic Win 7 Pro
Leica Biosystems Richmond, Inc.
23DKI5807
Not in Commercial Distribution

  • 00849832009863 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive
DELL FIXATION RING
KATENA PRODUCTS, INC.
AE-2186
In Commercial Distribution

  • 00841668128497 ()
AE-2186

  • Eyeball fixation instrument, reusable
Dell Swivel Toric Mark. W/Rotating Bezel
KATENA PRODUCTS, INC.
08-12120
In Commercial Distribution

  • 00841668119952 ()
08-12120

  • Corneal marker, reusable
Dell Fixed Toric Mark. W/ Rotating Bezel
KATENA PRODUCTS, INC.
08-12119
In Commercial Distribution

  • 00841668119945 ()
08-12119

  • Corneal marker, reusable
Dell Astigmatism Marker, (Nichamin)
KATENA PRODUCTS, INC.
08-121115
In Commercial Distribution

  • 00841668119891 ()
08-121115

  • Corneal marker, reusable
Dell Astigmatism Marker, 6 & 8mm Cord
KATENA PRODUCTS, INC.
08-121085
In Commercial Distribution

  • 00841668119853 ()

  • Length: 8 Millimeter
  • Length: 6 Millimeter
08-121085

  • Corneal marker, reusable
Dell Astigmatism Marker
KATENA PRODUCTS, INC.
08-12108
In Commercial Distribution

  • 00841668119846 ()
08-12108

  • Corneal marker, reusable
Denticator Prophy Cup, Regular Firm, Regular Size White 4-Web Cup, Metal Latch Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
530700
In Commercial Distribution

  • 10302735307001 ()
  • 00302735307004 ()
530700

  • Dental polishing cup, single-use
Young Elite Flex Prophy Cup, Latex Free, Extra Soft Pink Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
296051
In Commercial Distribution

  • 10302732960513 ()
  • 00302732960516 ()
296051

  • Dental polishing cup, single-use
Young Elite Original Prophy Cup, Latex Free, Soft Purple Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
296050
In Commercial Distribution

  • 10302732960506 ()
  • 00302732960509 ()
296050

  • Dental polishing cup, single-use
Young Pointed Polisher, Latex Free, Firm, Blue Ribbed Exterior, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
295722
In Commercial Distribution

  • 10302732957223 ()
  • 00302732957226 ()
295722

  • Dental polishing cup, single-use
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